NCT01713946 · OUTCOME
Long Term Evaluation: Percentage Change From Start of Everolimus in Seizure Frequency by Time Window
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures · Source last updated 2018-11-07
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percent change
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline (8-week period before start of everolimus), Week 7 to 18, Week 19 to 30, and 12 weeks thereafter up to Week 102
What was measured
Percentage change from start of everolimus in average weekly seizure frequency (SFcfe) = 100 × (SFe - SFtw) ÷ SFe where:
SFe is the average weekly seizure frequency in the 8-week period before start of everolimus SFtw is the average weekly seizure frequency in a 12-week time window A positive percentage change from start of everolimus (SFcfe) means a reduction in seizure frequency whereas a negative percentage change from start of everolimus (SFcfe) means an increase in seizure frequency.
Analysis population: The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid postbaseline efficacy evaluation.
Groups in this outcome
Everolimus LT Target of 3 to 7 ng/mL
Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
Everolimus HT Target of 9 to 15 ng/mL
Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
Placebo
Participants were randomized to receive placebo dispersible tablets for oral suspension.
Everolimus Long Term Evaluation (LTE)
Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 361 |
|---|
Reported measurements
Week 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 352 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 31.65 | Not reported | 28.51 | 36.09 | Not reported |
|---|
Week 30
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 335 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 35.74 | Not reported | 29.37 | 39.06 | Not reported |
|---|
Week 42
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 320 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 42.86 | Not reported | 34.44 | 48.15 | Not reported |
|---|
Week 54
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 299 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 46.05 | Not reported | 39.93 | 53.61 | Not reported |
|---|
Week 66
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 282 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 49.07 | Not reported | 38.26 | 55.56 | Not reported |
|---|
Week 78
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 252 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 51.69 | Not reported | 43.88 | 61.58 | Not reported |
|---|
Week 90
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 222 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 57.33 | Not reported | 47.37 | 67.01 | Not reported |
|---|
Week 102
Analysis denominator · Participants
| Group | Source count |
|---|
| Everolimus LT Target of 3 to 7 ng/mL | 0 |
|---|
| Everolimus HT Target of 9 to 15 ng/mL | 0 |
|---|
| Placebo | 0 |
|---|
| Everolimus Long Term Evaluation (LTE) | 191 |
|---|
Values in Percent change · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Everolimus Long Term Evaluation (LTE) | 59.69 | Not reported | 52.13 | 70.94 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG003
- lower Limit
- 28.51
- upper Limit
- 36.09
- value
- 31.65
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 352
- units
- Participants
- title
- Week 18
- categories
- measurements
- group Id
- OG003
- lower Limit
- 29.37
- upper Limit
- 39.06
- value
- 35.74
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 335
- units
- Participants
- title
- Week 30
- categories
- measurements
- group Id
- OG003
- lower Limit
- 34.44
- upper Limit
- 48.15
- value
- 42.86
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 320
- units
- Participants
- title
- Week 42
- categories
- measurements
- group Id
- OG003
- lower Limit
- 39.93
- upper Limit
- 53.61
- value
- 46.05
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 299
- units
- Participants
- title
- Week 54
- categories
- measurements
- group Id
- OG003
- lower Limit
- 38.26
- upper Limit
- 55.56
- value
- 49.07
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 282
- units
- Participants
- title
- Week 66
- categories
- measurements
- group Id
- OG003
- lower Limit
- 43.88
- upper Limit
- 61.58
- value
- 51.69
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 252
- units
- Participants
- title
- Week 78
- categories
- measurements
- group Id
- OG003
- lower Limit
- 47.37
- upper Limit
- 67.01
- value
- 57.33
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 222
- units
- Participants
- title
- Week 90
- categories
- measurements
- group Id
- OG003
- lower Limit
- 52.13
- upper Limit
- 70.94
- value
- 59.69
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 191
- units
- Participants
- title
- Week 102
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 361
- units
- Participants
- description
- Percentage change from start of everolimus in average weekly seizure frequency (SFcfe) = 100 × (SFe - SFtw) ÷ SFe where:
SFe is the average weekly seizure frequency in the 8-week period before start of everolimus SFtw is the average weekly seizure frequency in a 12-week time window A positive percentage change from start of everolimus (SFcfe) means a reduction in seizure frequency whereas a negative percentage change from start of everolimus (SFcfe) means an increase in seizure frequency.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL
- id
- OG000
- title
- Everolimus LT Target of 3 to 7 ng/mL
- description
- Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL
- id
- OG001
- title
- Everolimus HT Target of 9 to 15 ng/mL
- description
- Participants were randomized to receive placebo dispersible tablets for oral suspension.
- id
- OG002
- title
- Placebo
- description
- Participants who were treated with everolimus either in the Core or Extension phases of the study and were evaluated for longer term safety and efficacy.
- id
- OG003
- title
- Everolimus Long Term Evaluation (LTE)
- param Type
- MEDIAN
- population Description
- The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid postbaseline efficacy evaluation.
- reporting Status
- POSTED
- time Frame
- Baseline (8-week period before start of everolimus), Week 7 to 18, Week 19 to 30, and 12 weeks thereafter up to Week 102
- title
- Long Term Evaluation: Percentage Change From Start of Everolimus in Seizure Frequency by Time Window
- type
- SECONDARY
- unit Of Measure
- Percent change
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Preserved source evidence · Not medical advice
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